Registry for spontaneous intracranial hypotension and post-dural puncture headache
Official title: The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
Run by University Hospital Freiburg · NCT06711731 · Data updated 2026-11-12
This study is collecting information from people with spinal fluid leaks to better understand the causes and symptoms of headaches related to spontaneous intracranial hypotension and post-dural puncture headache.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | University Hospital Freiburg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Freiburg im Breisgau) |
| Status | Recruiting |
| Started | November 4, 2024 |
| Main results expected | December 4, 2034 |
| Study ends | December 4, 2036 |
| Registry record updated | December 2, 2024 |
| Trial ID | NCT06711731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with suspected spinal CSF leaks, characterized by new orthostatic symptoms or imaging suggestive of a leak.
✕Probably not a fit
Patients whose symptoms can be conclusively explained by another known diagnosis may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry aims to collect structured information on the frequency, causes, symptoms, and diagnostic procedures related to spinal cerebrospinal fluid (CSF) leaks, which can lead to chronic headache syndromes and other serious health issues. It focuses on two main conditions: spontaneous intracranial hypotension (SIH) and post-dural puncture headache (PDPH), both of which are often misdiagnosed. By gathering data from patients with suspected spinal CSF leaks, the registry seeks to improve awareness and understanding of these conditions, ultimately aiding in timely diagnosis and treatment. The study is observational and does not involve specific interventions.
Why it matters
Potential benefit: If successful, this registry could lead to improved diagnosis and treatment options for patients suffering from spinal CSF leaks.
How similar studies have gone: While there is increasing awareness of spinal CSF leaks, this registry represents a novel approach to systematically collect data on these conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with suspected spinal CSF leak based on one of the following * History of new orthostatic symptomes with or without prior spinal procedure * Imaging suggestive for spinal CSF leak 2. Informed consent Exclusion Criteria: a) Symptoms beeing conclusively explained by another known diagnosis
Where it's running
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Medical Center - University of Freiburg, Germany
Freiburg im Breisgau, Germany Recruiting
Study contacts
- Study coordinator: Katharina Wolf, Dr. med.
- Email: katharina.wolf@uniklinik-freiburg.de
- Phone: +49 761 270-50010
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TachoSil vs DuraSeal for Supporting Dural Sealing in Adults
This retrospective study looks at whether TachoSil works as well as DuraSeal to prevent CSF leaks or pseudomeningoceles after cranial or spinal surgeries in adults.
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Cerebrospinal fluid leak after brain tumor surgery
This project will look at adults having planned supratentorial craniotomy for intracranial tumors to see how often cerebrospinal fluid leaks occur and what complications they cause.
-
Sealant versus no sealant to prevent CSF leaks after endoscopic endonasal skull base surgery
We will try fibrin or synthetic sealants versus no sealant to see if they prevent postoperative CSF leaks in adults having endoscopic endonasal skull base surgery who are judged to be at low risk for leaks.
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Dural Sealant Used After Neurosurgery to Help Ensure Watertight Closure
This registry follows adults who receive Immiseal after neurosurgical dural repair to see how safe and effective it is in real-world use.
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Comparing two dural sealants for preventing cerebrospinal fluid leaks after brain surgery
This study is testing whether a new sealant called CraniSeal is as good as the existing DuraSeal at preventing leaks of spinal fluid after brain surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.